Janssen Pharmaceutica, the maker of RISPERDAL® (risperidone), the most frequently prescribed antipsychotic medication in the U.S., has sent a letter to health care providers to clarify the risks involved with the use of RISPERDAL®.
The letter has been provided in response to FDA instructions issued on the 19th of May 2004 regarding Janssen's “Dear Healthcare Provider” (DHCP) Letter for RISPERDAL® (risperidone) disseminated by Janssen Pharmaceutica, Inc. on November 10, 2003.
The FDA advised that the DHCP was misleadingly and failed to provide material information about RISPERDAL®®, which minimized potentially fatal risks associated with the drug. The DHCP also claimed to be safer than other drugs in its class without adequate substantiation.
"RISPERDAL® is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. RISPERDAL® is also indicated in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder," according to background information on the drug RISPERDAL®, issued by the FDA in its warning letter. It is approved for use as therapy alone or in combination with drugs called mood stabilizers, such as lithium or valproate.
More than 10 million people use RISPERDAL® which accounts for around $2 billion in annual sales for Janssen Pharmaceutica Products
Janssen Pharmaceutica Products is backed by Johnson & Johnson, its parent company.